ERAS in Elderly Colorectal Cancer Surgery

NCT06764888 | Completed DMC

• 1 other identifier: 202401646B0
• Study Type: observational
• Target: 1,392
• Locations: 1 country
• Sites: 1

Brief Summary

Enhanced recovery protocol consisted of a series of elements aiming to optimize and standardize perioperative care. This study aims to evaluate the safety and feasibility of a modified ERAS protocol following colorectal surgery in the elderly population, aged 65 years or older. This is a retrospective study based on prospectively collected data. Patient privacy has been carefully protected throughout the research process, and no aspect of this study interfered with or altered the patients' treatment or clinical care.

Conditions

ERAS; Colo-rectal Cancer; Elderly (people Aged 65 or More); Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (1)

• Short-term postoperative complications rate.

  Measurement outcomes included the rate of short-term postoperative complications, overall morbidity, early morbidity, reoperation rate, 30-day readmission rates and 30-day mortality rates. Postoperative complications were carefully recorded and classified using the Clavien-Dindo classification system for a standardised severity evaluation. These complications are critical for assessing surgical outcomes and ensuring patient safety. Early complications were defined as those occurring during the initial hospitalisation or within 30 days of surgery, while late complications were defined as those arising after the patient's discharge from the hospital.

  3 months

Secondary Outcomes (1)

• Days of Hospital Stay and Time to First Passage of Flatus

  3 months

Study Arms (1)

traditional care group

traditional care group

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From January 2018 to December 2022, comprehensive data on patients who underwent colorectal resection for malignancy at a single medical institute, Chang Gung Memorial Hospital, were prospectively collected and retrospectively reviewed.

You may qualify if:

• they underwent radical resection for colorectal cancer
• the procedure was minimally invasive surgery
• they were aged 65 or older
• they provided signed informed consent.

You may not qualify if:

• Patients who underwent emergency surgery for colorectal cancer.
• Patients with incomplete medical records or missing data relevant to the study.
• Patients with synchronous malignancies or a history of other cancers within the past five years.
• Patients with severe comorbidities (e.g., advanced cardiovascular, respiratory, or renal diseases) that contraindicate ERAS protocol implementation.
• Patients with preoperative metastatic disease or locally advanced tumors requiring palliative procedures.
• Patients who did not comply with or complete the ERAS protocol during the perioperative period.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 9, 2025
• Study Start: June 5, 2024
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: January 9, 2025

Record last verified: 2024-12

Locations

TW (1)